RWD SIG

Purpose

To increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Objectives

Our objectives include:

  • Facilitate sharing of case studies and experiences in this area
  • Collate and summarise publications, articles, presentations, training
  • Identify emerging news and trends
  • Organise and/or participate in workshops related to RWD
  • Collaborate with key stakeholder groups (EFSPI/PSI, EFPIA, ISPOR,  regulatory and academia)
  • Provide comments on RWD related guidelines, e.g. country-specific methods guidelines, FDA methods guidelines, ISPOR etc.
  • Develop/highlight best practices and recommendations
  • Influence industry practice and acceptance of approaches by regulators and other stakeholders

 

Who we are

NameCompany/Institution
Anny Stari (Chair)GSK
Peter Almgren

LEO Pharma

Anders Berglund 

Daiichi-Sankyo

Tobias Bluhmki 

Bristol Myers Squibb
Imi FaghmousKite Gilead
Fiona GrimsonUCB
Randi GrønNovo Nordisk
Richard GroveGSK

Alessandro Guasconi 

Chiesi Farmaceutici S.p.A.
Deepak Parashar  

Warwick University

Kostas Sechidis 

Novartis
Claire SmithAstraZeneca
Aijing ShangRoche
Barbara TorlinskaUniversity of Birmingham

Sudhir Venkatesan

AstraZeneca
Huajun WangGSK

Jixian Wang

Bristol Myers Squibb

Qing Wang 

Roche

Josephine Wolfram 

Astellas

Call for members

Frequency of Meetings

Monthly teleconferences

Upcoming Events

PSI VisSIG Wonderful Wednesdays

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Book Club

PSI are starting a book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.

PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

PSI Training Course: Use of Historical Data in Clinical Trials: An Evidence Synthesis Approach

In this short course, we will provide a statistical framework to incorporate external information into a trial. Bayesian Dynamic Borrowing designs based on the meta-analytic predictive (MAP) model will be detailed, and a practice session will be proposed with applications using the R package RBesT.

PSI Medical Statistics Careers Event

Our annual PSI Medical Statistics Careers Event, will be held online on Wednesday 2nd March 2022. The event will include a live online panel discussion and a virtual exhibition session.

Latest Jobs

(Senior/Principal) Clinical Data Scientist with focus on early Oncology Statistics (m/w/d)

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices.

Associate Director, Biostatistics, SARC

In this role you will consult in the design of complex and innovative studies and clinical trial programs as well as Leading DMC/DSMB processes.

Associate Director/Director (Supervisor), Statistical Science – Global Medical Affairs/Payer Biometrics

Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, decision making, analytics and interpretation.

Principal Biostatistician

Joining us as Principal Biostatistician you will be responsible for providing statistical support of global clinical development programs in neuroscience.